LONDON, 5 June (APM) - Malaria drug hydroxychloroquine showed no clinical benefit in a Phase III trial in hospitalised patients with Covid-19, the study's lead investigators announced on Friday.
The chief investigators of the Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial, professors Peter Horby and Martin Landray from the University of Oxford, said in a statement the study was established in March to test a range of potential drugs for Covid-19, including malaria drug hydroxycholoroquine.
The trial has enrolled over 11,000 patients from 175 NHS hospitals in the UK.
Hydroxycholoroquine has been touted by U.S. President Donald Trump and others as a possible treatment for Covid-19. It is currently being tested in numerous trials around the world.
The investigators of the RECOVERY study reviewed the unblinded data on the hydroxychloroquine arm of the trial based on a recommendation from the independent data monitoring committee.
They said: "We have concluded that there is no beneficial effect of hydroxychloroquine in patients hospitalised with Covid-19. We have therefore decided to stop enrolling participants to the hydroxychloroquine arm of the RECOVERY trial with immediate effect. We are now releasing the preliminary results as they have important implications for patient care and public health."
A total of 1,542 patients were randomised to hydroxychloroquine compared with 3,132 patients randomised to usual care alone. The investigators said there was no significant difference in the primary endpoint of 28-day mortality (25.7% hydroxychloroquine vs. 23.5% usual care). There was also no evidence of beneficial effects on hospital stay duration or other outcomes, they added.
"These data convincingly rule out any meaningful mortality benefit of hydroxychloroquine in patients hospitalised with Covid-19. Full results will be made available as soon as possible."
Peter Horby is professor of emerging infectious diseases and global health in the Nuffield Department of Medicine, University of Oxford, and chief investigator for the trial.
He said: "Hydroxychloroquine and chloroquine have received a lot of attention and have been used very widely to treat Covid patients despite the absence of any good evidence.
"The RECOVERY trial has shown that hydroxychloroquine is not an effective treatment in patients hospitalised with Covid-19. Although it is disappointing that this treatment has been shown to be ineffective, it does allow us to focus care and research on more promising drugs."
Martin Landray, professor of medicine and epidemiology at the Nuffield Department of Population Health, University of Oxford, and deputy chief investigator, said: "There has been huge speculation and uncertainty about the role of hydroxychloroquine as a treatment for Covid-19, but an absence of reliable information from large randomised trials.
"Today's preliminary results from the RECOVERY trial are quite clear - hydroxychloroquine does not reduce the risk of death among hospitalised patients with this new disease. This result should change medical practice worldwide and demonstrates the importance of large, randomised trials to inform decisions about both the efficacy and the safety of treatments."
Lancet study withdrawn
The RECOVERY trial news comes on the same day that a widely publicised study, which put the safety of hydroxychloroquine in Covid-19 patients into question, was withdrawn.
The Lancet medical journal pulled
the study after three of its authors retracted it, citing concerns about the quality and veracity of data in it.
The three authors of the study said Surgisphere, the company that provided the data, would not transfer the dataset for an independent review and they "can no longer vouch for the veracity of the primary data sources".
"We all entered this collaboration to contribute in good faith and at a time of great need during the Covid-19 pandemic. We deeply apologise to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused," The Lancet said.
The retracted study led to the suspension of a World Health Organization study of hydroxychloroquine last month, which restarted this week. (APMHE 67619
The benefits of hydroxychloroquine for Covid-19 patients have also been called into question by the U.S. National Institutes for Health (NIH) (APMHE 67046